Quality Assurance Auditor
Location: Lancaster, SC
Shift: Monday – Friday | 1st Shift
Salary: $70,000-$95,000/year + Annual Bonus Opportunity
We are seeking a Quality Assurance Auditor to develop and maintain an effective internal compliance program to support adherence to applicable regulations and quality standards. This role plans and conducts internal and external audits, manages supplier audit activities and corrective actions, and works with teams across the organization to strengthen compliance and inspection readiness.
What You’ll Do:
- Plan, schedule, and conduct internal and external audits to assess compliance with applicable regulations and quality requirements.
- Audit external suppliers, contract manufacturers, laboratories, and other service providers; maintain the supplier qualification program and Approved Vendor List in the quality management system.
- Coordinate external providers supporting international audits.
- Manage the supplier corrective action request (SCAR) program, assess the risk and significance of audit findings, and follow up to ensure corrective and preventive actions are appropriate and effective.
- Maintain audit, supplier, and vendor documentation in the quality management system.
- Track and report audit and compliance metrics; prioritize work to ensure audits, reports, and corrective actions are completed on time.
- Identify areas of potential noncompliance and support development or implementation of processes and policies to reduce risk.
- Support CAPA activities, regulatory inspection readiness, and training for internal teams on quality and compliance expectations.
- Provide Quality Assurance support for contract manufacturing activities, including product development, investigations, and CAPAs, as needed.
- Collaborate with Quality Assurance colleagues and teams across the organization.
- Perform other duties as assigned in support of Quality Assurance and company objectives.
Required Qualifications
- Bachelor’s degree in a science or technical field.
- 5+ years of Quality Assurance auditing experience in a cGMP environment, including at least five years of external supplier or vendor compliance auditing experience in an FDA-regulated industry.
- Experience conducting both internal and external audits.
- Working knowledge of 21 CFR Parts 210, 211, and 507, as well as dietary supplement regulations under 21 CFR Part 111.
- Flexibility to travel to supplier sites, sometimes with limited notice.
- Proficiency with Microsoft Office applications.
Preferred Qualifications
- ASQ Certified Quality Auditor (CQA) certification.
- Familiarity with SAP and quality management systems.
Work Authorization
•
Candidates must be authorized to work in the United States without employer sponsorship now or in the future.
Physical Requirements
- The role may require standing, walking, pushing, and pulling in manufacturing and clean-room environments, as well as wearing personal protective equipment appropriate to the audit setting.
Compensation & Benefits
- Competitive salary based on experience.
- Eligible for an annual performance bonus (up to 12% of annual earnings, based on company performance).
- Comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and career development opportunities.
10444630